A variety of medical conditions require afflicted individuals wear a brace, cast or some type of orthotic to accommodate and support the foot and ankle. The present device is intended particularly for people with a condition commonly referred to as "foot drop", as well as being for ankle and foot weaknesses and instability which may be brought on by any number of causes, including traumatic injury and disease.
Previously, a variety of appliances have been attempted for use with such conditions, with varying degrees of success. Common problems with the known art include: (1) difficulty in obtaining an appropriate fit, so that tissue irritation occurs, as well as misplacement of pressure on certain areas of the foot, ankle and/or associated leg, (2) inability of the wearer to ambulate, (3) tissue irritation caused by the material of the devices (4) discomfort caused by a large appliance attached to the foot and ankle, even when the wearer is resting; (5) difficulty in putting on and removing the appliance; and (6) some known devices have been quick to wear out or break, causing increased expense, inconvenience, and even risk of injury to the wearer. Known foot and ankle orthotic devices were generally either for ambulatory use only or non-ambulatory use only, not both. In other words, an orthotic designed to permit the user to walk was not adaptable for comfortable wearing while reclining, and vice versa. The following art provides examples:
U.S. Pat. No. 5,050,620, which issued to Cooper, discloses a padded ankle brace adjustably connected with hook and loop fastener straps. However, the Cooper brace is not adaptable to accommodate walking. The patent which issued to Chang, U.S. Pat. No. 5,250,021 shows a foot and ankle brace which is much more substantial than the Cooper device, and includes a shoe base and rigid supporting sides to resist twisting and rotational torque to the user's leg. The arch portion of the Chang device is adjustably connected by hook and loop fastener straps and the walking sole is formed to permit rocking motion, but is not removable in the manner of the present invention.
The patent which issued to Green et al., U.S. Pat. No. 4,587,962 discloses a tibia/ankle orthosis with a supporting jacket which can be tightened without applying too much torque to the patient's leg and supporting the foot during the process of the application. The Green et al. device is not adaptable for a walking-type splint, nor is it fully padded as is possible with the present orthosis. Similarly, the Lonardo device, (U.S. Pat. No. 3,976,059 discloses a simple L-shaped splint with hook and loop strap attachments and optional extensions to protect the supine user's toes from sheets and bed clothes. Lonardo also does not teach any adaptation of the splint for walking.
Two patents issued to Grim/Grim et al, (U.S. Pat. Nos. 5,329,705 and 5,464,385) disclose a rigid sole platform and rigid braces, which extend upwardly on each side of the user's leg. A padded liner is provided and an optional insole to help prevent sores from forming. A cushioned non-removable rocker sole is also disclosed, as is a walker devise with an open heel, to permit better air access to the foot, and air bladders, which can be selectively inflated.
Although the art reveals orthoses which have removably connected walking soles, none are structured as in the present case, for rapid and facile attachment and detachment of the walking plate by the user, without assistance from others or the use of tools, nor the combination of such advantages with other features of the present device. Examples of previous devices, which all have some form of an L-shaped ankle and/or foot splint, include the following:
The patent which issued to Hicks (U.S. Pat. No. 5,372,576) shows a padded therapeutic foot orthosis which, although having padding to cover the hard structures and protect the foot, does not connect the padding over the brace structure in the same manner presently proposed, with the rear pockets and an underfoot pocket with square cutout to accommodate the sole attachment mechanism. There is also no disclosure of attachment of the wrap to the brace in the manner presently described. In the patented Hicks brace, the leg extending portion and the foot supporting portion of the brace are each provided with a knurled edged nut and bolt arrangement for purposes of adjustable connection of a toe support extension portion which is connected beneath the rigid foot support.
A similar use of a nut and threaded bolt-in-slot arrangement is used in Bodine to attach a stabilizing/connecting bracket to the rigid leg support member of a foot and leg splint. However, Bodine does not disclose any walking sole.
The patent which issued to Wang (U.S. Pat. No. 5,421,822) discloses a complex and heavy apparatus for rehabilitating an injured leg, particularly the calf portion thereof. This patent discloses a means of connecting a very heavy, complex sole plate which is much more complicated and time consuming in use than the new structure for a foot and ankle orthosis with an optional walking sole, as described and claimed herein.
The patent that issued to Bieling (U.S. Pat. No. 5,460,600) for a universal foot splint shows a method for connecting a toe extension unit to the bottom of the splint. The apparatus includes a threaded nut and bolt arrangement in which an elongated track slideably receives the extension member and can be tightened down on the extension member after the nut and bolt arrangement is placed appropriately. Although the Bieling locking mechanism includes a turning member, there is no essentially fixed placement of the connection arrangement, as in the present case. Rather the Bieling extension member is slideable and does not appear to include any padding for comfort and tissue protection during walking, but rather has only a limited amount of padding for support for the foot and toe during recovery.
The patent which issued to Payton (U.S. Pat. No. 4,057,056) discloses a walking cast with a removable sole. Although the Payton cast includes an "L" shaped rigid support member which travels behind the leg and under the foot, and an over-wrap member which is adjustably applied with hook and loop fastener straps, it varies substantially from the present device in a number of ways. The deep rocker sole of Payton is attached by moving it transversely with relation to the bottom of the foot and connecting it beneath the arch of the foot with a tongue and groove style attachment, as well as by connecting the toe portion of the sole. Further, the over-wrap of Payton is more complex and time consuming to apply, having a front portion which is completely independent from the back and side portions of the wrap and which is connected therethrough by laborious threading of the connection straps through a plurality of rings on each side of the front portion.
A patent which issued to DeToro (U.S. Pat. No. 5,593,383) for a foot and ankle brace includes an "L" shaped construction with contoured leg support portion and a foot portion and a fabric padding which connects by straps. However, it does not show a quickly attachable and detachable walking sole which extends outwardly forwardly under the toes of the user, beyond the end of the rigid "L" shaped portion, nor the overall fabric construction which connects to the brace as in the present invention. In DeToro, the walking pad terminates forwardly under the ball of the foot and the toe portion is supported by the continuation forwardly of the rigid "L" shaped portion.
The Varn U.S. Pat. Nos. 5,569,173 and 5,569,174 both feature a foot orthosis with a detachable sole plate. The '173 patent shows an L-shaped leg and foot support member. A nut and bolt arrangement extends downwardly and attaches the sole portion to the toe extension portion. A optional walking pad can also be added beneath the rigid foot support portion by hook and loop strips attached, as by adhesive, to the top of the walking sole and the bottom of the foot support portion, and a hole is provided to receive the downwardly extending nut and bolt plate attachment. This nut-receiving opening in the sole in Varn does not serve as part of the walking sole connection, as in the present case. Rather, it serves to connect the toe-protection extension. This structure is seen also in Varn patent '174. Again, connection of the rubber walking sole is by hook and loop fastening straps.
By contrast, the device of the present invention permits both ambulatory and non-ambulatory functions, and is designed to permit quick and easy alteration of the device from one mode to the other in a manner heretofore unknown, along with a variety of other advantageous features in a single, economical and comfortable foot/ankle orthosis.